We have taken a different approach in that, as Jennifer has advised, it's just like bring out whats in the business plan. The context doesn't change so much over the course of a business planning cycle, so would a "log" be beneficial? The ISO requirements seem to want the quality management system to be aligned with the prganization's business and usually logs aren't created, are they?

The challenge is how Top Management will review the (9.3.2 b) changes in internal and external issues that are relevant to the QMS. It might be hard to do that if there is no document.

I am updating my QMS risk-based planner and will direct you to it soon, hopefully later today. I added a series of adapted SWOT pages in case people want to use them for their system and process planning. I'm updating the Instructions page now but must step out for awhile.

Okay here it is.

I have updated my Risk Based Planner to include a section for defining Context, as well as sheets to document SWOTs for departments/processes if the organization decides it is worthwhile to do so.

The Risk-Based Planner is meant to be a living document, suitable for top managers to define and review/update the management system Context, and process owners to define and address process risks.

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Why would you pay for auditing when you feel they are not doing you justice? I have replaced more than one auditor.

If someone has changed many Auditors within a CB then maybe it is time to change CBs.

Having someone review your system, in that snapshot in time, can not hurt the organization (in my opinion). Having the outside of the box review, as long as it is objective and not subjective, can only help an organization achieve their desired results. But, if Upper Management does not support the 3rd Party review then there is a Catch 22. You need the flow down from the top. Without that, it is highly probable that the system will fail, and it may cost existing and potential customers.

For a smaller company, I think incorporating this into the management review meeting minutes makes sense.

I think it makes sense with larger organizations too. That would be the group who reviews issues, interested parties etc.

But it's true that this tool was made for smaller organizations, or those who do not have another (or better) idea on how to do it. Overall I am tryinng to encourage people that this does not need to be rocket science. Don't overthink it.

I still have issues with this clause. Is this looking for a statement, or a list of different items ( as shown in the first few posts of this thread) or a combination of both? I feel like it should be a combination of both with the statement being a broad overview in 4.1 and then a list of the interested parties etc listed in 4.2. Or am i just not understanding this well enough?

Another thing I see as examples are PEST diagrams but I dont see how that fully describes the requirements of the clauses.

For 4.3 Determining the Scope, I have "This QMS is designed to ensure the manufacturing and assembly of precision aerospace components for commercial aircraft, defense, space, and medical diagnostics and implants are in accordance with all customer, statutory, and regulatory requirements." But again, the more i reread the clauses, i feel like that's not what i should have there.